Evaluation of TachoSil® Application on a Colorectal Anastomosis (TC-029-IM)

NCT00713661 | Completed Phase 2 Results DMC

• 2 other identifiers: TC-029-IM2007-007254-62
• Study Type: interventional
• Target: 25
• Locations: 3 countries
• Sites: 3

Brief Summary

The primary objective is to evaluate if the application of TachoSil® on a colorectal anastomosis is feasible and safe. The secondary objective is to establish and describe optimal application methods to be used for educational purposes in future trials.

Conditions

Colorectal Anastomosis

Keywords

Colorectal Anastomosis; Colorectal Resection; Tachosil

Outcome Measures

Primary Outcomes (1)

• The Primary Endpoint is the Feasibility of the TachoSil® Application, Reported by the Combined Assessment of the Investigator and External Assessor

  Evaluation of feasibility was assessed by investigator after application of the TachoSil® sponge on the anastomosis. A feasible application implied that the entire TachoSil® adhered and covered at least 1cm beyond the margins of the anastomotic line and that if more than one sponge was used, they overlapped by at least 1 cm. The score was assisted by video recording. To ensure an independent assessment, the recording was assessed by an external, blinded assessor. In case of discrepancies between the assessment of the investigator and the assessor, the application was regarded as not feasible.

  Day of surgery

Secondary Outcomes (1)

• The Secondary Endpoint is the Feasibility of the TachoSil® Application, Assessed by the Investigator.

  Day of surgery

Study Arms (1)

TachoSil®

EXPERIMENTAL

Drug: TachoSil®

Interventions

TachoSil® DRUG

Sterile, ready-to-use, absorbable sponge for intra-operative topical application. It consists of an equine collagen sponge coated with the fibrin glue components human fibrinogen and human thrombin. Surgery was performed according to the hospitals' local standards. When the anastomosis was performed, all enrolled subjects had TachoSil® applied around the anastomotic line. TachoSil® was therefore an add-on therapy.

TachoSil®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Has the patient given informed consent according to local requirements before any trial-related activities? A trial-related activity is any procedure that would not have been performed during the routine management of the subject.
• Is the subject 18 years of age or above?
• Is the subject scheduled for elective resection of the rectum?
• Is a colorectal anastomosis below the peritoneal reflexion planned?
• For females of childbearing potential:
• Does the patient use an acceptable contraceptive method (contraceptive pills, injection of prolonged gestagen, subdermal implantation, hormonal vaginal devices, transdermal patches or intrauterine device (IUD))?
• Is the blood or urine pregnancy test negative?

You may not qualify if:

• Is the subject scheduled for emergency resection of the rectum?
• Does the subject suffer from inflammatory bowel diseases?
• Does the subject have a history of hypersensitivity reactions after application of human fibrinogen, human thrombin and/or collagen of any origin?
• Does the subject participate or plan to participate in another clinical trial during the trial period?
• For females of childbearing potential:
• Is the subject pregnant or breast feeding?
• Did the subject receive any fibrin sealant/glue, excluding TachoSil® , during surgery?

Sponsors & Collaborators

• Nycomed: lead

Study Sites (3)

Investigational site

Berlin, Germany

Location

Investigational site

Utrecht, Netherlands

Location

Investigational site

Dartford, Kent, United Kingdom

Location

MeSH Terms

Interventions

TachoSil

Results Point of Contact

• Title: Clinical Trial Operations
• Organization: Nycomed

clinicaltrials@nycomed.com

+45 4677 1111

Study Officials

• Nycomed Clinical Trial Operations

  Headquarters

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2008
• First Posted: July 11, 2008
• Study Start: June 1, 2008
• Primary Completion: June 1, 2009
• Study Completion: July 1, 2010
• Last Updated: May 8, 2012
• Results First Posted: March 2, 2012

Record last verified: 2012-02

Locations

GB (1); DE (1); NL (1)